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Effectiveness of Simulation With Nursing Students in the Care of Patients With Sepsis

Primary Purpose

Learning Process in Nursing Graduation, Stress

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High-Fidelity Simulation
Low-Fidelity Simulation
Sponsored by
University of Brasilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Learning Process in Nursing Graduation focused on measuring Simulation, Stress, Psychological, Nursing, Education, Simulation Training, Learning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Students approved in the discipline related to nursing care for adult and elderly patients;
  • Aged over 18 years.

Exclusion Criteria:

  • Who have experience in the health field (firefighters and nursing technicians, among others);
  • Members of the Health Simulation League;
  • Those who do not complete all stages of the research.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    High-Fidelity Simulation

    Low-Fidelity Simulation

    Arm Description

    First, students will go through an inverted class on sepsis. Then, they will be submitted to high-fidelity simulation scenarios to care for patients with sespe. After the scenario, the students' physiological parameters (blood pressure, heart rate, body temperature, respiratory rate and oxygen saturation) will be measured. After the scenario, students will go through a reflective debriefing session.

    First, students will go through an inverted class on sepsis. Then, they will be submitted to low-fidelity simulation scenarios to care for patients with sespe. After the scenario, the students' physiological parameters (blood pressure, heart rate, body temperature, respiratory rate and oxygen saturation) will be measured. After the scenario, students will go through a feedback session.

    Outcomes

    Primary Outcome Measures

    Cognitive Performance (Baseline)
    Students' knowledge about nursing care in sepsis measured using a structured questionnaire with six multiple-choice questions
    Cognitive Performance (Post-test)
    Students' knowledge about nursing care in sepsis measured using a structured questionnaire with six multiple-choice questions
    Cognitive Performance (Retention)
    Students' knowledge about nursing care in sepsis measured using a structured questionnaire with six multiple-choice questions

    Secondary Outcome Measures

    Student stress (Baseline)
    Assessment of students' stress intensity with pedagogical activities through the application of the Kezkak Stress Scale. This scale has 31 items of the Likert type of 4 points, being: 1 - Nothing stressful; 2 - A little stressful; 3 - Very stressful; 4 - Extremely stressful. The value 1 means less stress and 4 more stress.
    Student stress (Post-test)
    Assessment of students' stress intensity with pedagogical activities through the application of the Kezkak Stress Scale. This scale has 31 items of the Likert type of 4 points, being: 1 - Nothing stressful; 2 - A little stressful; 3 - Very stressful; 4 - Extremely stressful. The value 1 means less stress and 4 more stress.

    Full Information

    First Posted
    August 2, 2020
    Last Updated
    August 10, 2020
    Sponsor
    University of Brasilia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04512183
    Brief Title
    Effectiveness of Simulation With Nursing Students in the Care of Patients With Sepsis
    Official Title
    Effectiveness of Simulation in the Cognitive, Physiological and Emotional Sphere of Nursing Students in Caring for Patients With Signs of Sepsis: Crossover Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    March 30, 2021 (Anticipated)
    Study Completion Date
    August 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Brasilia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Simulation is an active teaching strategy capable of reproducing real situations and allowing practical experiences, in which the student is the protagonist of his own knowledge. Scientific evidence highlights, that exposure to the unknown or new can generate stress to the individual, but when dosed, to a certain extent it can increase the level of knowledge. Not infrequently, the lack of stress control can trigger physiological and subjective changes resulting from the increase in its level, such as situations that include the implementation of simulation scenarios in pedagogical teaching models.
    Detailed Description
    Objective: To evaluate the effect of simulation (high and low fidelity) on the cognitive, physiological and emotional sphere of nursing students in caring for patients with signs of sepsis. Hypothesis of the study: Null hypothesis: Students undergoing high-fidelity simulation will show similar levels of stress, cognitive performance and retention of knowledge in relation to those who will perform low-fidelity simulation in patients with signs of sepsis. Alternative hypothesis: The cognitive performance and stress will be higher in students who experience high fidelity simulation when compared to students who experience low fidelity simulation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Learning Process in Nursing Graduation, Stress
    Keywords
    Simulation, Stress, Psychological, Nursing, Education, Simulation Training, Learning

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    High-Fidelity Simulation
    Arm Type
    Experimental
    Arm Description
    First, students will go through an inverted class on sepsis. Then, they will be submitted to high-fidelity simulation scenarios to care for patients with sespe. After the scenario, the students' physiological parameters (blood pressure, heart rate, body temperature, respiratory rate and oxygen saturation) will be measured. After the scenario, students will go through a reflective debriefing session.
    Arm Title
    Low-Fidelity Simulation
    Arm Type
    Active Comparator
    Arm Description
    First, students will go through an inverted class on sepsis. Then, they will be submitted to low-fidelity simulation scenarios to care for patients with sespe. After the scenario, the students' physiological parameters (blood pressure, heart rate, body temperature, respiratory rate and oxygen saturation) will be measured. After the scenario, students will go through a feedback session.
    Intervention Type
    Other
    Intervention Name(s)
    High-Fidelity Simulation
    Intervention Description
    Teaching strategy based on high-fidelity simulation, which simulates the reality of health care to promote meaningful learning.
    Intervention Type
    Other
    Intervention Name(s)
    Low-Fidelity Simulation
    Intervention Description
    Teaching strategy based on low-fidelity simulation, which simulates the reality of health care using less technological and less interactive mannequins.
    Primary Outcome Measure Information:
    Title
    Cognitive Performance (Baseline)
    Description
    Students' knowledge about nursing care in sepsis measured using a structured questionnaire with six multiple-choice questions
    Time Frame
    Applied before the intervention
    Title
    Cognitive Performance (Post-test)
    Description
    Students' knowledge about nursing care in sepsis measured using a structured questionnaire with six multiple-choice questions
    Time Frame
    Applied immediately after the intervention
    Title
    Cognitive Performance (Retention)
    Description
    Students' knowledge about nursing care in sepsis measured using a structured questionnaire with six multiple-choice questions
    Time Frame
    Applied thirty days after the intervention
    Secondary Outcome Measure Information:
    Title
    Student stress (Baseline)
    Description
    Assessment of students' stress intensity with pedagogical activities through the application of the Kezkak Stress Scale. This scale has 31 items of the Likert type of 4 points, being: 1 - Nothing stressful; 2 - A little stressful; 3 - Very stressful; 4 - Extremely stressful. The value 1 means less stress and 4 more stress.
    Time Frame
    Before the intervention
    Title
    Student stress (Post-test)
    Description
    Assessment of students' stress intensity with pedagogical activities through the application of the Kezkak Stress Scale. This scale has 31 items of the Likert type of 4 points, being: 1 - Nothing stressful; 2 - A little stressful; 3 - Very stressful; 4 - Extremely stressful. The value 1 means less stress and 4 more stress.
    Time Frame
    Immediately after the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Students approved in the discipline related to nursing care for adult and elderly patients; Aged over 18 years. Exclusion Criteria: Who have experience in the health field (firefighters and nursing technicians, among others); Members of the Health Simulation League; Those who do not complete all stages of the research.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marcia CS Magro, PhD
    Phone
    5561982690888
    Email
    marciamagro@unb.br
    First Name & Middle Initial & Last Name or Official Title & Degree
    Barbara S Rodrigues, Graduate
    Phone
    5561982409357
    Email
    mio.barby@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marcia CS Magro, PhD
    Organizational Affiliation
    University of Brasilia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29924167
    Citation
    Boostel R, Felix JVC, Bortolato-Major C, Pedrolo E, Vayego SA, Mantovani MF. Stress of nursing students in clinical simulation: a randomized clinical trial. Rev Bras Enferm. 2018 May;71(3):967-974. doi: 10.1590/0034-7167-2017-0187. English, Portuguese.
    Results Reference
    background
    PubMed Identifier
    31166535
    Citation
    Kaneko RMU, Lopes MHBM. Realistic health care simulation scenario: what is relevant for its design? Rev Esc Enferm USP. 2019 May 30;53:e03453. doi: 10.1590/S1980-220X2018015703453. English, Portuguese.
    Results Reference
    background
    PubMed Identifier
    25741028
    Citation
    Bingham AL, Sen S, Finn LA, Cawley MJ. Retention of advanced cardiac life support knowledge and skills following high-fidelity mannequin simulation training. Am J Pharm Educ. 2015 Feb 17;79(1):12. doi: 10.5688/ajpe79112.
    Results Reference
    background
    PubMed Identifier
    28099632
    Citation
    Machado FR, Assuncao MS, Cavalcanti AB, Japiassu AM, Azevedo LC, Oliveira MC. Getting a consensus: advantages and disadvantages of Sepsis 3 in the context of middle-income settings. Rev Bras Ter Intensiva. 2016 Oct-Dec;28(4):361-365. doi: 10.5935/0103-507X.20160068. No abstract available.
    Results Reference
    background
    PubMed Identifier
    26633154
    Citation
    Englert NC, McDermott D. Back to Fundamentals: Using High- and Low-Fidelity Simulation to Provide Reinforcement of Preventative Measures for Sepsis. Crit Care Nurs Q. 2016 Jan-Mar;39(1):14-23. doi: 10.1097/CNQ.0000000000000097.
    Results Reference
    background

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    Effectiveness of Simulation With Nursing Students in the Care of Patients With Sepsis

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